Blinded continuous monitoring in clinical trials with recurrent event endpoints

In studies with recurrent event endpoints, misspecified assumptions of event rates or dispersion can lead to underpowered trials or overexposure of patients. Specification of overdispersion is often a particular problem as it is usually not reported in clinical trial publications. Changing event rates over the years have been described for some diseases, adding to the uncertainty in planning. To mitigate the risks of inadequate sample sizes, internal pilot study designs have been proposed with a preference for blinded sample size reestimation procedures, as they generally do not affect the type I error rate and maintain trial integrity. Blinded sample size reestimation procedures are available for trials with recurrent events as endpoints. However, the variance in the reestimated sample size can be considerable in particular with early sample size reviews. Motivated by a randomized controlled trial in paediatric multiple sclerosis, a rare neurological condition in children, we apply the concept of blinded continuous monitoring of information, which is known to reduce the variance in the resulting sample size. Assuming negative binomial distributions for the counts of recurrent relapses, we derive information criteria and propose blinded continuous monitoring procedures. The operating characteristics of these are assessed in Monte Carlo trial simulations demonstrating favourable properties with regard to type I error rate, power, and stopping time, ie, sample size.     

Hidden Resources and Barriers in Career Learning Assessment With Adolescents Vulnerable to Discrimination

The authors maintain that the social learning theory of career development and counseling has not been applied to diverse populations. To address this gap in the literature, the authors conducted a qualitative analysis of interviews with 21 middle school students in a low‐income, culturally diverse, inner‐city public school. Four themes emerged, reflecting the influence of discrimination on participants' career learning: contextual barriers and resources for learning, and psychological barriers and resources for learning. The authors provide a conceptual framework for assessing resources and barriers and a rationale for why these aspects often remain hidden or unexamined in career assessment with clients who are vulnerable to discrimination.     

Estimating household structure in ancient China by using historical data: a latent class analysis of partially missing patterns

Summary.  Social data often contain missing information. The problem is inevitably severe when analysing historical data. Conventionally, researchers analyse complete records only. Listwise deletion not only reduces the effective sample size but also may result in biased estimation, depending on the missingness mechanism. We analyse household types by using population registers from ancient China (618–907 AD) by comparing a simple classification, a latent class model of the complete data and a latent class model of the complete and partially missing data assuming four types of ignorable and non-ignorable missingness mechanisms. The findings show that either a frequency classification or a latent class analysis using the complete records only yielded biased estimates and incorrect conclusions in the presence of partially missing data of a non-ignorable mechanism. Although simply assuming ignorable or non-ignorable missing data produced consistently similarly higher estimates of the proportion of complex households, a specification of the relationship between the latent variable and the degree of missingness by a row effect uniform association model helped to capture the missingness mechanism better and improved the model fit.     

Quasi-maximum likelihood estimation and inference in dynamic models with time-varying covariances

We study the properties of the quasi-maximum likelihood estimator (QMLE) and related test statistics in dynamic models that jointly parameterize conditional means and conditional covariances, when a normal log-likelihood os maximized but the assumption of normality is violated. Because the score of the normal log-likelihood has the martingale difference property when the forst two conditional moments are correctly specified, the QMLE is generally Consistent and has a limiting normal destribution. We provide easily computable formulas for asymptotic standard errors that are valid under nonnormality. Further, we show how robust LM tests for the adequacy of the jointly parameterized mean and variance can be computed from simple auxiliary regressions. An appealing feature of these robyst inference procedures is that only first derivatives of the conditional mean and variance functions are needed. A monte Carlo study indicates that the asymptotic results carry over to finite samples. Estimation of several AR and AR-GARCH time series models reveals that in most sotuations the robust test statistics compare favorably to the two standard (nonrobust) formulations of the Wald and IM tests. Also, for the GARCH models and the sample sizes analyzed here, the bias in the QMLE appears to be relatively small. An empirical application to stock return volatility illustrates the potential imprtance of computing robust statistics in practice.     

Rural/Urban Differences in Child Growth and Survival in Bolivia

Abstract Using data from a national survey in Bolivia and from a regional sample of poor communities in two regions of Bolivia, we model the effects of community conditions, household characteristics, and social relations on child health as measured by child mortality and stunted growth. Based on national data, children in rural areas are twice as likely to die before the age of two than are children in large cities, and about one‐third of the children in rural areas are stunted. Including measures of community, household, and maternal characteristics accounts for at least two‐thirds of the urban/rural difference in child health. We conclude that expansion of health services, improvements in household and community sanitation, and socioeco‐nomic development are all needed to overcome the rural disadvantage in child health.     

Naivety and Family Therapy An Interview with John Carpenter

Family therapists have been naive about families, the pressures on them and the contexts of therapy. Therapists should be clear about their roles, sensitive to families' experience of therapy, and resist the temptation to mystify therapy. John Carpenter is Senior Lecturer in Mental Health, University of Kent, Canterbury, England and Co-Editor of Journal of Family Therapy. He was a guest keynote speaker at the 1991 Australian Family Therapy Conference in Brisbane, and this interview took place shortly afterwards in Melbourne.     

Bayesian analysis of directed graphs data with applications to social networks

Summary.  A fully Bayesian analysis of directed graphs, with particular emphasis on applica- tions in social networks, is explored. The model is capable of incorporating the effects of covariates, within and between block ties and multiple responses. Inference is straightforward by using software that is based on Markov chain Monte Carlo methods. Examples are provided which highlight the variety of data sets that can be entertained and the ease with which they can be analysed.     

Age Cohort, Ancestry, and Immigrant Generation Influences in Family Relations and Psychological Well-Being among Black Caribbean Family Members

Immigration is contributing to the U.S. population becoming increasingly ethnically diverse. This article examines the role of family relations and well-being among different generations of Black Caribbean immigrants. Family disruptions, such as migration, can have complex effects on the support networks and emotional well-being of family members. Data from a recently completed national study of American Blacks in the United States, however, reveal significant similarities across ancestry and immigrant status in family contact, solidarity and well-being. It is concluded that intrafamilial relations may serve to overcome barriers of geographical distance in providing comparable levels of contact, solidarity, and well-being for both U.S.-born and immigrant Black Caribbean family members of different generations. Because of the increasing numbers of immigrant elders, these sources of family support will become increasingly more important in bridging the gaps between government resources and needed assistance in an aging society.     

The Access/Impact Problem and the Green and Gold Roads to Open Access

The research access/impact problem arises because journal articles are not accessible to all of their would-be users; hence, they are losing potential research impact. The solution is to make all articles Open Access (OA; i.e., accessible online, free for all). OA articles have significantly higher citation impact than non-OA articles. There are two roads to OA: the “golden” road (publish your article in an OA journal) and the “green” road (publish your article in a non-OA journal but also self-archive it in an OA archive). Only 5% of journals are gold, but over 90% are already green (i.e., they have given their authors the green light to self-archive); yet only about 10–20% of articles have been self-archived. To reach 100% OA, self-archiving needs to be mandated by researchers' employers and funders, as the United Kingdom and the United States have recently recommended, and universities need to implement that mandate.